The Therapeutic Goods Administration (TGA) in Australia has issued guidance (21 June, 2024) on the "Regulatory Obligations for Exempt Medical Devices". This guidance is essential for manufacturers and sponsors of medical devices that are exempt from TGA pre-market assessment but still need to comply with certain regulatory requirements.
Exempt Medical Devices: Medical devices that are exempt from TGA pre-market assessment but still need to meet certain regulatory requirements to ensure their safety and performance.
Some medical devices are exempt from needing to be included in the ARTG before import, export or supply.
The guidance aims to clarify the regulatory obligations for manufacturers and sponsors of exempt medical devices, including labeling, advertising, and post-market monitoring requirements. The TGA provides a list of medical devices that are exempt from pre-market assessment. This list is regularly updated and includes devices such as low-risk devices, custom-made devices, and certain in vitro diagnostic devices.
To be exempt from pre-market assessment, a device must meet specific criteria outlined by the TGA. These criteria are based on the risk posed by the device and its intended use. Despite being exempt, these products are still regulated by us. Sponsors and manufacturers still need to comply with ongoing responsibilities. These include:
Recall of medical devices
Compliance with the Therapeutic Goods Advertising Code
Compliance with the Essential Principles (EP)
The TGA conducts compliance checks to ensure that manufacturers and sponsors of exempt devices are meeting their regulatory obligations. Non-compliance can result in regulatory action, including fines or product recalls.
If a manufacturer or sponsor fails to comply with the regulatory requirements for exempt devices, the TGA may take enforcement actions, such as issuing infringement notices or initiating court proceedings.For more detailed information, you can access the full guidance document here.